Device for obtaining stool samples

ABSTRACT

The device is usable by a patient to self-obtain a relatively constant volume stool sample for use in testing for gastro-intestinal bleeding. The device is a multi-layered pad which can be dispensed by a physician or the like to the patient and which the patient can use in privacy. The device is used in the same manner as toilet tissue to obtain the stool sample after defecation. Excess stool sample is discarded in the toilet and an appropriate amount of the stool sample is retained on the pad. The pad is then sealed and returned to the physician or testing laboratory hermetically sealed. The seal is broken, the test is performed, and then the pad is resealed hermetically and discarded.

The device of this invention is a continuation-in-part of my co-pendingapplication, Ser. No. 55,636, filed July 9, 1979.

This invention relates to a stool sampling device which can be used by apatient, in the same manner as toilet tissue, to obtain a relativelyconstant volume stool sample which can then be tested for signs ofgastro-intestinal bleeding.

One medical procedure frequently used on physicians' patients involvesthe obtaining of a stool sample which is tested for traces of blood todetermine the presence or absence of gastro-intestinal bleeding. Thistest is a conventional precaution for patients having an establishedhistory of gastro-intestinal bleeding and will also be used on patientswho are anemic, and who complain of gastro-intestinal discomfort. Thistest is also used as a screening test during routine physicalexaminations.

A manner most commonly used to obtain the stool sample is by thephysician's donning a rubber glove and manually inserting a finger intothe rectum of the patient to obtain a stool smear. The stool is thentransferred to a piece of absorbent paper and effective amounts ofdetecting agents such as guaiac, ortho-tolidine, or ortho-dianisidineand hydrogen peroxide are applied to the stool whereupon the presence ofblood in the stool will cause a bluish coloration to appear. No colorchange indicates the absence of occult blood in the stool, andtherefore, the absence of gastro-intestinal bleeding. This method ofobtaining the stool sample is not sanitary and unpleasant for thepatient and for the physician.

Another method for obtaining the required stool samples involves the useof a kit sold under the brand name Hemoccult by Smith Kline Diagnostics.The kit includes a packet made of paper and formed somewhat similarly toa match book. The packet has a tab-slot interlock which can be opened sothat the packet can be unfolded. Inside of the packet there is disposeda sample-receiving pad which has been treated with guaiac, one of thedetecting chemicals referred to above. A sample-obtaining wooden stickis included with the kit. The kit is designed for use by the patient inprivacy as follows. The kit is given to the patient by the physician, orobtained at a pharmacy upon directive of the physician. The patienttakes the kit home, and it is used subsequent to defecation. A scrapingof the bowel movement is obtained by the patient from the toilet withthe stick and some of the scraped material is transferred to the padfrom the stick. The contaminated stick must then be discarded by thepatient. The packet flap is then reclosed and the packet and sample arethen returned to the physician's office for examination. It will beappreciated that this procedure is to some extent more desirable thanthe first above-described procedure in that it may be performed inprivacy. Nevertheless, it is also an unclean procedure with no provisionfor guarding against contamination, and the manner of disposition of thespecimen on the pad is somewhat distasteful in that thestool-contaminated pad is generally discarded in the trash in anunsealed state. Furthermore, the patient is instructed to bring or mailthe stool-contaminated pad to the physician. The mailing of thestool-contaminated pad in a non-hermetically sealed state is unsanitaryand contrary to U.S. postal regulations.

Other prior art stool sampling devices are disclosed in U.S. Pat. Nos.3,718,431; 3,672,351; and 3,996,006.

I have devised a device which is used to procure stool samples, andwhich may be used in a conventional manner, in the privacy of one'shome, or toilet in a physician's clinic or office, and which is cleanand contamination-free and which is disclosed in my co-pendingapplication referred to above.

This invention relates to an improvement in my earlier concept whichimprovement enables a relatively constant volume of stool to be obtainedwhen the sampling device is used. Briefly, the device of this inventionis a pad or packet having a number of constituent layers, the pad beingused to obtain the stool specimen in the same manner as toilet tissueafter defecation. Excess amounts of stool are removed from the pad bytearing off one of the constituent layers and discarding that layer inthe toilet, that layer being biodegradable. The layer which is torn fromthe pad includes a perforated portion which overlies a stool retentionportion with the layer having a perforated screening portion whichensures that a relatively constant volume of stool is deposited on theretention portion when the device is used. The pad is then hermeticallysealed and returned to the physician's office. The device is thuscontamination and odor-free during transport. A sheet of thin,semi-transparent paper coated with the guaiac reagent is included in thepad at an appropriate location. To examine the specimen for blood, thepad is opened and a second reagent, hydrogen peroxide, is applied to thesemi-transparent guaiac impregnated thin paper overlying the stoolsample. Inspection for color change (easily visible through thesemi-transparent paper) is made, and the pad is resealed and discarded.In this manner, the test is performed quickly, and the discarded pad isboth contamination and odor free.

It is, therefore, an object of this invention to provide a device forthe taking of stool samples to be used in performing blood-detectingtesting.

It is an additional object of this invention to provide a device of thecharacter described which can be used by a patient in the privacy of hishome and at his convenience.

It is yet another object of this invention to provide a device of thecharacter described which is used in a conventional manner, and which iscontamination and odor free.

It is a further object to provide a device of the character describedwhich enables a relatively constant volume of stool to be taken fortesting when the device is used.

These and other objects and advantages of this invention will be morereadily understood from the following detailed description of apreferred embodiment thereof taken in conjunction with the accompanyingdrawings, in which:

FIG. 1 is an exploded perspective view of a preferred embodiment of adevice made in accordance with this invention;

FIG. 2 is a perspective view of the device of FIG. 1;

FIG. 3 is a perspective view of the device shown after the layercontaining excess stool has been removed and discarded;

FIG. 4 is a perspective view of the device shown after the hermetic sealhas been achieved to render the device contamination and odor free; and

FIG. 5 is a perspective view of the device showing how access to thestool sample is made for performing the test.

Referring now to the drawings, there is illustrated a preferredembodiment of the stool sampling device of my invention. The device,denoted generally by the numeral 2, is a multi-layered assemblage whichhas the general pliancy and feel of a thickened piece of toilet tissue.The upper layer 4 is a sheet of semi-flexible material such aspolyethylene plastic; paper-plastic laminate, or the like. On one sideof the upper sheet 4, there is disposed an area comprising a pluralityof small openings 6. The half of the sheet 4 which contains the openings6 has deposited thereon a layer 8 of soft fibrous cellulosic materialwhich is flocked onto the sheet 4 and provides the flocked half thereofwith a soft texture similar to tissue paper. Thus, one half of the sheet4 will have a soft, tissue-like texture, and the other half will have asmooth, shiny texture, like plastic.

Disposed beneath the openings 6, there is a somewhat enlarged pad 10 ofabsorbent paper, or the like. An adhesive layer 12 underlies the pad 10and serves to secure the pad 10 and the flocked half of the overlyingsheet 4 to a bottom sheet 14, which is formed from an impermeablematerial such as a paper-plastic laminate, a foil-plastic laminate, orthe like. The bottom sheet 14 is also semi-flexible so as to maintainthe overall flexibility and pliability of the entire laminate. The layer12 may take the form of a double-sided sticky tape, or may be simply alayer of sticky, resealable adhesive coated directly on the sheet 14.Disposed on the half of the bottom sheet 14 not covered by the adhesivelayer are a plurality of adhesive buttons 16 which serve to releasablyadhere the nonflocked half of the sheet 4 to the sheet 14. The sheet 14is provided with an opening 18 on one of its halves, and the opening 18is closed and sealed by means of a conforming closure member 20 madefrom the same material as the sheet 14. The closure member 20 includes apull tab 22 and a border 24 of resealable adhesive which serves tosecure the closure member 20 to the sheet 14. On the inside surface ofthe sheet 14 and overlying the opening 18 is a thin paper sheet 15 whichis relatively transparent and porous. This sheet 15 is preimpregnatedwith the guaiac reagent in dry form. This sheet 15 may be made from thetype of tissue commonly used for cleaning lenses.

The appearance of the device 2 as dispensed by the physician, pharmacy,or the like, in its ready-to-use condition, is shown in FIG. 2.

The device 2 is used to obtain a stool sample in the following manner.Immediately after defecation, the device is used in the same manner asone uses toilet tissue, and the flocked portion of the device is drawnacross the anus, whereby a stool smear is obtained on the flocking 8 andon the portion of the pad 10 which underlies the openings 6. It will beappreciated that the openings 6 will act to screen the stool from thepad 10 so that the stool sample will be deposited on the pad 10 in aplurality of spots which will be volumetrically controlled by the areaof each opening 6. The sheet 4 is then pulled away from the remainingportions of the device and discarded into the toilet where it is flushedaway with the stool. It will be noted that the adhesive buttons 16 willeasily allow the corresponding half of the sheet 4 to be removed fromthe sheet 14 (as shown partially in phantom in FIG. 2) whereupon theremainder of the sheet 4 and the flocked portion 8 thereon will bepeeled off of the resealable adhesive layer 12.

After the sheet 4 has been removed from the device 2, the latter appearsas shown in FIG. 3. It will be noted that the pad 10, upon whichmultiple spots of stool have been deposited, remains adhered to theadhesive layer 12. The half S of the sheet 14 is then folded over on topof other half S' of the sheet 14 to form a pouch configured as shown inFIG. 4. The folded-over half S is pressed against the exposed surface ofthe adhesive layer 12 so as to hermetically seal the resulting pouchwhereby contamination and odor from the encased stool sample isprevented. It will be noted that the folding operation brings the sealedopening 18 into overlying relationship with the pad 10. It will also benoted that the folding operation brings the guaiac impregnated papersheet 15 into overlying relationship with the stool spots on the pad 10.

The sealed pouch is then delivered to the physician's office, testinglaboratory, or the like, wherein the encased stool sample will be testedfor occult blood. To expose the stool sample for testing, the closuremember 20 is peeled back from the opening 18, as shown in FIG. 5. Thehydrogen peroxide is then applied to the stool sample on the pad 10through the guaiac sheet 15. Application of the hydrogen peroxide to thssheet 15 places the guaiac in solution whereby both reagents are appliedto the stool spots and further increases the transparency of the sheet15. The presence of occult blood in the sample will be indicated by ablue color which will be visible through the paper sheet 15. After thetest has been performed, the closure member 20 is resealed over theopening 18 and the used pouch is discarded, in an hermetically sealedcondition, for subsequent disposal, as by incineration or the like. Itwill be noted that, during the testing procedure, the underlying portionof the sheet 14 provides an impermeable barrier which prevents reagents,fecal material, viruses, bacteria, or the like from seeping through thepouch onto the laboratory bench, etc.

It will be readily appreciated that the device of this inventionprovides a means for obtaining a relatively constant volume stool samplewhich is simple and natural to use, which can be used by a patient inprivacy, and which circumvents the embarrassing aspects of the prior artdevices and procedures. The sample, once obtained, is hermeticallysealed whereby contamination and odor problems are avoided. Stillfurther, the device enables the actual test to be performed without thepossibility of reagent or contamination leakage occurring, and alsoenables the discarded tested stool sample to be contained in anhermetically sealed pouch.

Since many changes and variations of the disclosed embodiments of theinvention may be made without departing from the inventive concept, itis not intended to limit the invention otherwise than as required by theappended claims.

What is claimed is:
 1. A stool sampling device for obtaining direct analstool samples, said device comprising:(a) a first sheet of pliantimpermeable material; (b) a pad secured to one side of said first sheet,said pad being operable to receive a stool smear when said device isdrawn across a patient's anus after defecation; (c) a second sheet ofpliant material disposed on said first sheet, said second sheetoverlying said one side of said first sheet, and said second sheetincluding stool volume controlling openings therethrough aligned withsaid pad; (d) first releasable adhesive means securing said second sheetto said first sheet whereby said second sheet can be peeled off of saidfirst sheet after a stool smear has been deposited on said pad; (e)means for hermetically sealing said pad within said first sheet after astool smear has been deposited on said pad; (f) means forming an openingin said first sheet which opening is aligned with said pad when thelatter is sealed within said first sheet; (g) a pliant impermeable coversheet hermetically sealing said opening in said first sheet; and (h)second releasable adhesive means securing said cover sheet to the otherside of said first sheet, said second adhesive means forming meanswhereby said cover sheet can be peeled away from said first sheet touncover said opening in said first sheet to expose said pad for theapplication of detecting reagents to the stool smear, and whereby saidcover sheet can be resealed to said first sheet after the stool smearhas been tested.
 2. The stool sampling device of claim 1, furthercomprising a reagent-impregnated sheet of relatively transparent paperadhererd to said first sheet and overlying said opening on the side ofsaid first sheet opposite said cover sheet.
 3. A stool sampling devicefor obtaining direct anal stool samples, said device comprising:(a) afirst elongated sheet of pliant impermeable material having opposedlateral half portions; (b) a pad secured to one side of said firstsheet, said pad being situated on one of said half portions of saidfirst sheet, said pad being operable to receive a stool smear when saiddevice is drawn across a patient's anus after defecation; (c) a secondsheet of pliant material overlying substantially all of said one side ofsaid first sheet, said second sheet including a plurality of stoolvolume-measuring openings therethrough aligned with said pad, theobverse surface of at least the portion of said second sheet whichoverlies said one of said half portions of said first sheet beingflocked with a layer of absorbent fibrous material; (d) first releasableadhesive means securing said second sheet to said first sheet wherebysaid second sheet can be peeled off of said first sheet after a stoolsmear has been deposited on said pad, at least a portion of said firstadhesive means providing means for hermetically sealing said pad withinsaid first sheet when the other of said half portions of said firstsheet is folded over said one of said half portions of said first sheetafter removal of said second sheet; (e) means forming an opening in saidfirst sheet through said other half portion of said first sheet, saidopening being aligned with said pad when said pad is hermetically sealedwithin said first sheet; (f) a sheet of relatively transparent papersecured to said first sheet in overlying relationship with said opening,said sheet being impregnated with an occult blood detecting reagent; (g)a pliant impermeable cover sheet hermetically sealing said opening insaid first sheet; and (h) second releasable adhesive means securing saidcover sheet to the other side of said first sheet, said second adhesivemeans forming means whereby said cover can be peeled away from saidfirst sheet to uncover said opening in said first sheet to expose saidsheet of relatively transparent paper for the application of a detectingreagent to said sheet of relatively transparent paper and therethroughto the stool smear, and whereby said cover sheet can be resealed to saidfirst sheet after the stool smear has been tested.